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Iron Deficiency clinical trials

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NCT ID: NCT05256004 Completed - Heart Failure Clinical Trials

Cardiac Biomarkers and Iron Status in Hemodialysis Patients

Start date: June 1, 2022
Phase:
Study type: Observational

Background: Peripheral arterial disease (PAD) a condition characterized by atherosclerotic occlusive disease of the lower extremities is commonly observed in patients with chronic kidney disease (CKD) patients, particularly those on dialysis. We conducted detailed biomarkers such as thrombospondin and related inflammatory biomarkers for the risk of developing and presence of PAD. Thrombospondin-4 (TSP-4) is an extracellular matrix protein of the vessel wall. Despite bench evidence, its significance in the clinical setting of chronic kidney disease (CKD) is missing Methods: This is a cross-sectional, single-center study. A cohort of 450 patients aged 20 or over, who have been on HD for at least 3 months prior to enrollment (Dec 1, 2021) will be included. TSP-4 and TSP-1 will be measured in HD patients using a commercially available ELISA. PAD is diagnosed by the ankle-brachial index (ABI) We will measure related blood biomarkers such as serum hs-cTnT, N-terminal probrain natriuretic peptide, s-Klotho and FABP-4.

NCT ID: NCT05233709 Completed - Iron-deficiency Clinical Trials

The Effect of Ovotransferrin and Lactoferrin on Iron Absorption From Ferrous Sulfate in Adult Women

OTf
Start date: April 25, 2022
Phase: N/A
Study type: Interventional

OTf is a monomeric glycoprotein of 686 amino acid residues and, as a member of the transferrin family, folds into two homologous globular lobes, each containing a single reversible Fe3 + binding site located within the interdomain cleft of each lobe. A comparison of apo (metal-free) and holostructures shows that iron binding or release in OTf occurs via a mechanism that involves opening or closing domains. human lactoferrin, transferrin, and OTf share the same reversible iron binding mechanism. Lactoferrin (Lf) is a 77 kDa glycosylated protein highly concentrated in human and bovine milk and can exist in an apo (metal free) state or can bind two ferric ions with very high affinity (k = 1022 M-1) forming holo-Lf . It has been recently reported that the addition of apo-Lf to a test meal containing FeSO4 significantly increased (+56%) iron absorption in young infants [19]. Despite these positive results in infants, to our knowledge, the ability of Lf to improve iron absorption from FeSO4 has not yet been assessed in adult women. OTf and Lf will be tested as iron absorption enhancers by comparing the fractional iron absorption with that of FeSO4, the most widely used iron supplement. This study will provide information on how to improve iron absorption.In a randomized single-blind crossover study, the iron bioavailability is determined by means of stable iron isotope technology via the incorporation of stable isotopes from intrinsically labeled compounds into the erythrocytes 14 days after the study product.

NCT ID: NCT05221957 Not yet recruiting - Colorectal Cancer Clinical Trials

Effects of Preoperative Correction of Anemia With Intravenously Iron in Colorectal Cancer Patients.

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to examine the effects of anemia correction with intravenous administered iron on clinical outcomes and the immune response on the tumor in patients with planned colonic- or rectal cancer surgery. The study will be performed as a retrospective propensity score-matched cohort study with an examination of immune response in tumor and clinical outcomes, between patients with anemia without correction with iron(III)isomaltoside, non-anemic patients, and anemic patients treated with iron(III)isomaltoside prior to surgery. Propensity score matching will ensure identification of controls from a pool of patients treated at the Department of Surgery, Zealand University Hospital. The two control groups will be: an anemic historical control group (group 1), and a non-anemic concurrent control group (group 2). Group 3 will be the treatment group, with patients with anemia and treated with iron(III)isomaltoside. The study period of cases undergoing i.v. treatment will be 1st of February 2017 to 31st of October 2019 with approximately 70 cases included

NCT ID: NCT05220800 Not yet recruiting - Colorectal Cancer Clinical Trials

Effects of Intravenous Administered Iron in Non-anemic Iron Deficient Patients With Colorectal Cancer

NAIDIC
Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

This double-blinded clinical randomized trial with a 1:1 recruitment ratio between placebo and the active group will aim to investigate the effects of intravenously administered iron in non-anemic iron deficient patients on physical capacity, immunological cells and their function prior to surgery. A total of 134 patients with colorectalcancer will be included in the study. Study outline: After initial inclusion the patient will undergo baseline testing with cardiopulmonary exercise test (CPET), then followed by an infusion of a weight dependent dosage of iron(III)isomaltoside or placebo. Then at the closest possible time to the surgery the patient will have drawn bloodwork and be re-tested by (CPET). The patient will be followed after surgery with evaluation of several outcomes including quality of recovery and complications. Further, the effects of the intervention on the patients immune function will be evaluated by two different methods: 1) by changes in neutrophil-to-lymphocyte ratio between baseline and preoperative bloodwork and 2) by evaluation mRNA expression in the tumor specimen by the Nanostring pancancer immune panel

NCT ID: NCT05217836 Recruiting - Sepsis Clinical Trials

Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.

Start date: September 24, 2021
Phase:
Study type: Observational

Anemia is a common health problem. Depending on a geographical region, anemia affects even 50% of population. Among patients admitted to the intensive care unit (ICU) anemia may affect as much as 66% of patients. Moreover, many patients develop anemia during the ICU stay. In general population the most common cause of anemia is iron deficiency (ID). The investigators lack information on the incidence of ID and anemia of inflammation (AI) with absolute ID (mixed type of anemia: AI + IDA) or functional ID (AI) in patients with sepsis or septic shock hospitalised in the ICU. Therefore, the aim of the study is to improve diagnosis of iron deficiency (ID) and anemia of inflammation (AI) with absolute ID (AI + IDA) or functional ID (AI) in patients with sepsis or septic shock. ID have negative effects on the body and is associated with impaired production of proteins responsible for transport of oxygen in the blood (hemoglobin) and oxygen storage (myoglobin), and impaired immune function. Development of anemia is associated with well documented complications: organ hypoxia, myocardial infarction, stroke, infection. Replenishment of iron at this early stage may potentially prevent IDA. It is advantageous to replenish iron stores in order to avoid these complications, especially in patients with sepsis or septic shock. In IDA red blood cell transfusion is not recommended as it leads to other numerous complications. Therefore the patients presenting with laboratory results suggesting ID will receive divided doses od parenteral iron. Monitoring of iron replenishment will be based on a new laboratory parameter- reticulocyte hemoglobin equivalent.

NCT ID: NCT05185024 Completed - Clinical trials for Iron Deficiency Anemia

Daily Oral Iron Supplementation for Replenishment of Depleted Iron in Adults

IRON-RELOAD
Start date: January 19, 2022
Phase: N/A
Study type: Interventional

The study is designed as a parallel, randomized, double blind, three-arm single-center study exploring the efficacy and safety of 12-week once daily oral dosing of iron for correction of overall iron status in 150 otherwise healthy iron-deficient adults presenting with or without mild microcytic anemia. Three iron-containing preparations in the form of either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid will be tested. Potential study participants will be recruited from the general population of 18-50 year old adults. Participant eligibility will be determined by screening for hemoglobin and ferritin (in combination with C-reactive protein) levels in a sample of venous blood. Eligible individuals will be invited to participate in the study. Enrolled participants will be randomized into one of three intervention groups in a 1:1:1 ratio, receiving either Ferrous Sulfate Capsules, >Your< Iron Forte Capsules, or >Your< Iron Forte Liquid. Efficacy and safety of the assigned interventions will be evaluated through analyses of relevant hematological (hemoglobin, red blood cell indices) and biochemical (ferritin, transferrin saturation) iron-related parameters and reported adverse events after the first 4 and after a total of 12 weeks of intervention.

NCT ID: NCT05178407 Active, not recruiting - Anemia Clinical Trials

Effect of Household Use of Multiple Micronutrient-fortified Bouillon on Micronutrient Status Among Women and Children in Two Districts in the Northern Region of Ghana

Start date: January 16, 2023
Phase: N/A
Study type: Interventional

Background: Micronutrient (MN) deficiencies are severe and widespread in West Africa, particularly among young children and women of reproductive age. Bouillon is a promising food fortification vehicle because the product is centrally processed on large scale, consumed by most households in West African countries (even rural, poor households), and consumed by most members of the household in relatively constant amounts. However, several important research questions remain regarding whether the use of fortified bouillon would be feasible and effective for preventing or reducing micronutrient deficiencies in communities where such deficiencies are common. Specifically, no studies have assessed the impacts of multiple micronutrient-fortified bouillon on micronutrient status. The West Africa Condiment Micronutrient Innovation Trial (CoMIT) Project aims to address this gap, to inform future discussions around fortification of bouillon cubes and related products. Objective: This study aims to assess the impacts of household use of multiple micronutrient-fortified bouillon cubes (containing iodine in addition to vitamin A, folic acid, vitamin B12, iron, and zinc), compared to control bouillon cubes fortified with iodine only, on: 1. Micronutrient status among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 2. Hemoglobin concentrations among women 15-49 years of age and children 2-5 years of age after 9 months of intervention 3. Breast milk micronutrient concentrations among lactating women 4-18 months postpartum after 3 months of intervention Methods: This randomized, controlled doubly-masked trial will be conducted in the Kumbungu and Tolon districts in the Northern Region of Ghana, where prior data indicate that deficiencies in the selected nutrients are common. Potential participants will be: 1) non-pregnant non-lactating women of reproductive age (15 - 49 years old), 2) children 2-5 years of age, and 3) non-pregnant lactating women 4-18 months postpartum. Eligible participants will be randomly assigned to receive household rations of one of two types of bouillon cubes: 1. a multiple micronutrient-fortified bouillon cube containing vitamin A, folic acid, vitamin B12, iron, zinc, and iodine, or 2. a control cube containing iodine only Each participant's household will receive a specific amount of bouillon cube every 2 weeks, and households will be advised to prepare their meals as usual, using the study-provided cubes. The trial duration will be 9 months (38 weeks) for non-pregnant, non-lactating women and children 2-5 years of age, and 3 months (12 weeks) for lactating women. The primary outcomes will be changes from baseline to endline in concentrations of haemoglobin and biomarkers of micronutrient status. Secondary outcomes will include change in prevalence of anaemia and micronutrient deficiency; dietary intake of bouillon and micronutrients; inflammation, malaria, and morbidity symptoms; and children's anthropometric measures and child development.

NCT ID: NCT05153278 Completed - Clinical trials for Iron Deficiency Anemia

IV Iron Versus Standard Treatment for Iron Deficiency Anemia in the Emergency Department

Start date: October 26, 2018
Phase:
Study type: Observational

The investigators will retrospectively collect data of patients infused at UMC's emergency department (ED) with long acting irons (ferric carboxymaltose, iron dextran, iron sucrose, etc.), in addition, patients infused with blood products, with intent to treat iron deficiency anemia (IDA). Patient records reviewed will be from patients who were infused at UMC ED from January 2013 to June 2018. Primary aim of analysis will be to investigate superiority between interventions implemented for treating IDA. In addition, the investigators will utilize data to characterize patients who used ED services as an avenue to receive treatment for IDA. Further, the investigators will conduct cost analysis between different IDA directed treatments administered in the ED at UMC.

NCT ID: NCT05126901 Recruiting - Anemia Clinical Trials

Evaluate the Safety and Efficacy of Ferric Maltol Oral Suspension vs. Ferrous Sulfate Oral Liquid in Children and Adolescents Aged 2 to 17 Years With Iron-deficiency Anaemia, With a Single Arm Study in Infants Aged 1 Month to Less Than 2 Years

FORTIS
Start date: October 4, 2021
Phase: Phase 3
Study type: Interventional

The objective of the study is to compare the safety and gastrointestinal tolerability of ferric maltol oral suspension and ferrous sulfate oral liquid in children and adolescents aged 2 years to 17 years, and assess the safety and tolerability of ferric maltol oral suspension in children 1 month to less than 2 years, in the treatment of iron deficiency anaemia during the 12 weeks treatment period.

NCT ID: NCT05105438 Completed - Clinical trials for Iron Deficiency Anemia

Alternate Day vs. Daily Iron Supplementation in Iron Depleted Women

Start date: December 16, 2021
Phase: N/A
Study type: Interventional

Iron deficiency (ID) with or without anemia is a major public health problem worldwide, especially in women of reproductive age. Iron supplementation can be an effective strategy to prevent and treat ID and iron deficiency anemia (IDA). Recent studies suggests that giving oral iron every other day would be an optimized dosing regimen with maximized absorption and a lower incidence of gastrointestinal side effects compared to consecutive day dosing. Long-term trials in which participants and investigators are blinded to the dosing interval with iron status and gastrointestinal side effects as study outcomes are needed.